In case of Injury

Potential subjects must be informed as to whether the institution or the investigator will pay for the costs of medical care or hospitalization for injuries sustained as a direct result of participation in the research. (In general, research-related injury costs are not covered by the sponsors, except in the case of industry-sponsored protocols such as a drug company clinical trial.) If applicable, this section of the consent form should indicate whether the subject’s family or dependents will be compensated for death or disability resulting from a research-related injury. The subject also has a right to know who will provide care and treatment, and whom to contact in this circumstance. Within the medical school, for protocols in which the principal investigator is not a physician, the supervising physician should be listed. For sponsor-initiated or industry-sponsored protocols, this section of the consent form should reflect the content of the indemnification clause of the sponsor contract. More specifically stated, it is customary for the sponsor to assume the costs of care associated with research-related injuries. For minimal-risk protocols, the investigator should consult with the IRB, study sponsor, National Institutes of Health (NIH), and/or study site to see if this section of the consent form is necessary. However, this section is necessary for all protocols that are assessed as presenting greater than minimal risk. For examples of how to write this section, please refer to the consent template, the checklist, and the DHHS OHRP website